P4399Inspiratory muscle training and functional electrical stimulation in heart failure with preserved ejection fraction: results from a randomized clinical trial

Background: The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms. Methods: One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire. Results: The trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic. Conclusions: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04252287.

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Home-based inspiratory muscle training for management of older patients with heart failure with preserved ejection fraction: does baseline inspiratory muscle pressure matter?

European Journal of Cardiovascular Nursing ◽

10.1177/1474515119855183 ◽

2019 ◽

Vol 18 (7) ◽

pp. 621-627 ◽

Cited By ~ 4

Author(s):

Patricia Palau ◽

Eloy Domínguez ◽

José María Ramón ◽

Laura López ◽

Antonio Ernesto Briatore ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Inspiratory Muscle ◽

Inspiratory Muscle Training ◽

Inspiratory Pressure ◽

Preserved Ejection Fraction ◽

Muscle Training ◽

Maximum Inspiratory Pressure ◽

Home Based ◽

Patients With Heart Failure

Background:Heart failure with preserved ejection fraction is a clinical syndrome characterised by reduced exercise capacity. Some evidence has shown that a simple and home-based programme of inspiratory muscle training offers promising results in terms of aerobic capacity improvement in patients with heart failure with preserved ejection fraction. This study aimed to investigate whether the baseline inspiratory muscle function predicts the changes in aerobic capacity (measured as peak oxygen uptake; peak VO2) after a 12-week home-based programme of inspiratory muscle training in patients with heart failure with preserved ejection fraction.Methods:A total of 45 stable symptomatic patients with heart failure with preserved ejection fraction and New York Heart Association II–III received a 12-week home-based programme of inspiratory muscle training between June 2015 and December 2016. They underwent cardiopulmonary exercise testing and measurements of maximum inspiratory pressure pre and post-inspiratory muscle training. Maximum inspiratory pressure and peak VO2were registered in both visits. Multivariate linear regression analysis was used to assess the association between changes in peak VO2(Δ-peakVO2) and baseline predicted maximum inspiratory pressure (pp-MIP).Results:The median (interquartile range) age was 73 (68–77) years, 47% were women and 35.6% displayed New York Heart Association III. The mean peak VO2at baseline and Δ-peakVO2post-training were 10.4±2.8 ml/min/kg and +2.2±1.3 ml/min/kg (+21.3%), respectively. The median (interquartile range) of pp-MIP and Δ-MIP were 71% (64–92) and 39.2 (26.7–80.4) cmH2O, respectively. After a multivariate analysis, baseline pp-MIP was not associated with Δ-peakVO2(β coefficient 0.005, 95% confidence interval −0.009–0.019, P=0.452).Conclusions:In symptomatic and deconditioned older patients with heart failure with preserved ejection fraction, a home-based inspiratory muscle training programme improves aerobic capacity regardless of the baseline maximum inspiratory pressure.

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